The trial is a randomized, double-blinded, dummy-controlled study designed to evaluate the efficacy and safety of ThermoDox in combination with radiofrequency ablation (RFA) compared to RFA-alone. This 40 center, 600-patient study is projected to enroll patients over approximately an 18 month period, and will conclude by fourth quarter of 2009.
In addition, the submission of Celsion’s clinical trial authorization application for the Phase III protocol has been accepted by China SFDA, with authorization to enroll patients expected in August 2008.